1. Field of the Invention
This invention relates generally to compositions for tissue repair and methods for formulation thereof; and more particularly to compositions containing a therapeutic amount of stem cell released molecules for stimulating cytogenesis, cytoprotection, immune modulation, and pain relief in a targeted tissue region, such as opthalmic tissue, and the like.
2. Description of the Prior Art
It is widely known that stem cells are capable of producing and secreting certain molecules collectively referred to herein as “stem cell released molecules” (SRM), including for example: growth factors, cytokines, anti-oxidants, micro-RNA, mucins, and other molecules. A number of experimental therapies have emerged in the art that incorporate one or more stem cells for the treatment of a myriad of health related diseases and disorders.
Although various treatments have been investigated, these treatments have focused on providing live stem cells. Certain disadvantages related to treatment compositions consisting of live stem cells includes uncertainty of whether the provided cells are indeed alive at the time of delivery to the target tissue, whether the cells reach the target tissue, and whether the provided cells are capable of producing and releasing SRM's for facilitating a repair response in vivo.
As technologies advance and stem cell lines and other requisites become available, there is a continued need to develop formulations for treatment of tissue related diseases and associated symptoms.
By way of example, a common ophthalmic condition known as “dry eye” or “ocular surface disease” is generally understood to be caused by a problem with the quality of the tear film that lubricates the eyes. However, the tear film has long been thought to comprise three or more layers, of which a middle layer of the tear film has long been thought to include water for moisturizing the eyes. More recently, research has shown that the tear film of those with ocular surface disease generally lacks sufficient mucins and other naturally occurring molecules that would be present in a healthy patient. Thus, modern research confirms that a primary cause of ocular surface disease is generally a lack of mucins and other molecules for cellular repair and proliferation within the tear film as opposed to a reduction in the moisture content of the tear film itself. Accordingly, there has been much research in the field for seeking improved treatments for ocular surface disease, or dry eye.
Other ocular surface diseases include conjunctivitis, corneal erosion, keratitis, and corneal ulcers.
In the prior art, treatments for dry eye focused on providing moisture to the eye, and thus included various saline solutions, and other moisturizing solutions. One problem with these solutions includes that repeated use of such solutions can flush important proteins and other molecules from the eye. Without these naturally occurring molecules, the eyes are restricted from healing, and thus what is a temporary relief of pain and discomfort by providing a moisturizing solution to the eye, in fact may be a cause of further damage by flushing out important molecules. Thus, a limitation includes that prior art compositions fail to restore important biological molecules to the eye where such molecules would be beneficial to the healing process.
Although ocular surface disease, and ophthalmic compositions are described herein, this invention is not limited to these applications and compositions. Instead, the above details are provided as an example of certain limitations in the art. The invention will be further described hereinafter, and the scope of the invention should not be construed as limited by the above examples as those having skill in the art would recognize the features and benefits herein as applied to various alternative indications.